PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 80213250130
Access comprehensive regulatory information for PROSTATE SPECIFIC ANTIGEN (PSA) FREE in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80213250130 and manufactured by FUJIREBIO DIAGNOSTICS AB. The registration is held by PHAREBEE DIAGNOSTICOS COMERCIO IMPORTACAO E EXPORTACAO DE PRODUTOS LTDA with validity until Jan 09, 2026.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including ABBOTT IRELAND DIAGNOSTIC DIVISION, DIASORIN ITALIA S.P.A., and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80213250130
25351398944200570
64128853000196
Company Information
Dates and Status
Jan 09, 2006
09/01/2026
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
CanAg PSA EIA
FUJIREBIO DIAGNOSTICS AB
80213250128
Jan 09, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
CanAg PSA EIA
Not specified
80213250128
Jan 09, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA LIVRE EIA
Not specified
80048490047
May 10, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA LIVRE EIA
MONOBIND, INC
80048490047
May 10, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
FASTLINE FIA fPSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220286
Aug 18, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
Not specified
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
Not specified
10033121064
May 28, 2024